Documentation, Resources & Implementation Milestones Presented - - PowerPoint PPT Presentation
Session 1 Documentation, Resources & Implementation Milestones Presented by: Nick Halsey Data Standardisation and Analytics An agency of the European Union Agenda Why is EudraVigilance changing? How is EudraVigilance changing?
An agency of the European Union
Presented by: Nick Halsey Data Standardisation and Analytics
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amendments to Regulation (EC) No 726/2004 and Directive 2001/83/EC, followed by the addition of Commission Implementing Regulation (EU) No 520/2012 in June 2012.
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messages
the relevant NCA.
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will apply as from six months after the publication of the Commission notice about the full functionality of the EU portal and database, and no earlier than 28th May 2016.
an electronic database for the reporting of SUSARs and annual safety reports. The database shall be a module of the EudraVigilance database.
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standard 27953-2:2011
available, in the submission of ISO ICSR messages
SUSARs reporting by sponsors to EudraVigilance; This form would be ISO ICSR 27953-2:2011 (E2B(R3)) compliant.
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follows:
States and to the Agency and the European Commission.
their pharmacovigilance obligations.
appropriate levels of access to the EudraVigilance database, while guaranteeing personal data protection.
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routing to NCAs
legislation)
signal detection (respecting EU data protection legislation)
professionals and the public for all medicines authorised in the EU
with IDMP standards based on Article 57 data) by 1 July 2016 including backwards and forwards conversion tools for E2B(R2)/(R3) messages
users and volume of data
the risks of unauthorised access)
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collaboration with Member States and the Commission to address required changes
in December 2013 and are subject to an independent audit (“auditable requirements”)
database has achieved full functionality and the system meets the functional specifications based on
following the announcement by the Board
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functionalities implemented in the EV system.
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configuration changes may be needed to support E2B(R3) messages including acknowledgments from EV.
fulfilling the MAH’s legal obligations, MAHs should ensure that modifications to their submission systems are configured and tested well in advance of the planned implementation.
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system supporting the submission of E2B(R3) ICSRs, using the new simplify testing process with EMA.
months prior to the new EV system going live in order to give time for any issues to be addressed
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E2B(R3) format is further elaborated in the EU Individual Case Safety Report (ICSR) Implementation Guide (EMA/51938/2013 )
IDMP standard, serves as the dictionary for medicinal product information until the ISO IDMP standards implementation
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to EudraVigilance only, including EEA non-serious within 90 days.
report directly to EudraVigilance prior to move to centralised reporting .
for the manual data entry of non-serious EEA cases into EudraVigilance, taking into account that the number of non- serious cases received is generally higher than serious cases.
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– MAH Signal validation and management process
detection and analytical reporting functions (e.g. electronic reaction monitoring report and ICSR line listings).
register their staff to have access to it.
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to the current process for the submission of SUSARs for clinical trials approved through the Clinical Trials directive 2001/20/EC.
2001/20/EC will continue to have the same SUSAR reporting requirements as specified in the directive for a transition period
to the NCA that has approved the trial through establishing an agreement between the sponsor and the NCA concerned. The NCA will then forward these SUSARs to EV.
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systems at least 6 months prior to implementation in order to be ready once the new EudraVigilance system is implemented.
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for all users accessible through the EMA website
train the trainer approach might be
Flexible training paths
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Pharmacovigilance Operations New EudraVigilance Functionalities New EudraVigilance Functionalities - IT
E-learning Guidance Webinars Introduction to training offering by the EMA New EV functionalities and 2010 pharmacovigilance legislation Implementing ISO ICSR/ICH E2B R3 How to prepare for simplified adverse reaction reporting in the EU Revised EV Access policy – how does it impact
Revised GVP guidelines – updates and impact Revised Signal Detection Guideline Revised GVP Module VI Revised GVP Module IX Pharmacovigilance Operations Support webinar How to register with EudraVigilance and EVDAS EV/EVDAS Functionalities webinar ISO ICSR standard implementation for IT system developers Gateway adaptations for ISO ISCR/ACK message exchange with Eudravigilance Instructions on how to test ICSR submissions to EV EVDAS Report Manual Webport user guide for ADR website EVDAS training for MAHs EudraVigilance export manager and ICSR download Overview of reporting process for EV users Introduction to EV system components and system functionalities All MAH users will have access to all training course. The learning path aims to indicate course best suited for each stakeholder group Medical Literature Monitoring by EMA – what’s new Medical Literature Monitoring service MAH’s level 1 access via EVDAS
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MAHs should consider developing a communication plan to ensure that the necessary information is circulated within their own organisation and with other organisations that they work with.
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http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500196029
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http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000149.jsp&mid=WC0b01ac05800250b5
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Care professional
possibility
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products, the identification of the concerned product with regard to its manufacturing is important
primary source has been contacted for this information but is unable to provide it
information is missing
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component(s) additional fields are available in the ISO ICSR to capture specific information about the device component(s)
that the device component may have led to the adverse reaction experienced by the patient or in cases of device failure.
different to the medicinal product “box” level batch/lot number
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always be part of the ICSR message even if ICH/EU IGs classifies those fields as optional. In such situations a nulflavor will be permitted
IG allows some fields to be null however these fields are mandatory in the EU e.g Reporter Qualification, Literature Reference(s) & Study Registration Country
systems and for displaying in data entry tools
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5/10/WC500196023.xlsx
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(Optional)
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp? webContentId=WC500196025
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http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=53825
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http://eudravigilance.ema.europa.eu/xsd/multicacheschemas/MCCI_IN200100UV01.xsd
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